UMBRELLA SUNSCREEN- octinoxate titanium dioxide lotion 
CA-BOTANA INTERNATIONAL

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6236 Umbrella Sunscreen Lotion

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

ALOE VERA LEAF, ALUMINUM STARCH OCTENYLSUCCINATE, ASCORBIC ACID, ASCORBYL PALMITATE, BORON NITRIDE, CETOSTEARYL ALCOHOL, CETEARYL ISONONANOATE, CITRIC ACID MONOHYDRATE, CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, ETHYLHEXYLGLYCERIN, GLYCERIN, SUNFLOWER OIL, ISOMALT, LECITHIN SOYBEAN, MACADAMIA OIL, NIACIN, PANTHENOL, PHENOXYETHANOL, LECITHIN SOYBEAN, POTASSIUM SORBATE, PROPANEDIOL, ROSA MOSCHATA OIL, ROSEMARY, SODIUM BENZOATE, HYALURONATE SODIUM, TETRASODIUM IMINODISUCCINATE, TOCOPHEROL, GRAPE SEED OIL, WATER

Sunscreen

Titanium Dioxide, Octinoxate

For external use only.
Avoid contact with eyes.
Keep out of reach of children.
Do not apply to open wounds.
STOP USE AND ask a doctor if condition worsens or
symptoms persist for more than seven days, discontinue
use of the product.

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

Package label principal display panel

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UMBRELLA SUNSCREEN 
octinoxate titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.8 g  in 113.4 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE8.5 g  in 113.4 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ISOMALT (UNII: S870P55O2W)  
SOYBEAN OIL (UNII: 241ATL177A)  
MACADAMIA OIL (UNII: 515610SU8C)  
NIACIN (UNII: 2679MF687A)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPANEDIOL (UNII: 5965N8W85T)  
ROSA MOSCHATA OIL (UNII: J99W255AWF)  
ROSEMARY (UNII: IJ67X351P9)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TETRASODIUM IMINODISUCCINATE (UNII: GYS41J2635)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-010-02113.4 g in 1 TUBE; Type 0: Not a Combination Product11/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2012
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Registrant - RODOLFO UGELSTAD (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-010)

Revised: 10/2023
Document Id: 07da204d-03e5-5010-e063-6394a90ad41b
Set id: 5c6011ea-94e6-43e1-b00f-06cc2b402127
Version: 17
Effective Time: 20231016
 
CA-BOTANA INTERNATIONAL